Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators.

To develop a comprehensive item library of patient-reported, immunotherapy-related adverse events (irAEs) that draws from and expands on the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Literature review and iterative expert input. Based on a literature review of irAEs, we developed a framework of immunotherapy classes and their associated symptoms. Clinical experts then reviewed iterations of symptom summaries and item maps linked to the immunotherapy framework. Experts provided content review and feedback was shared across experts until consensus was reached. The iterative process facilitated creation of a Primary Symptom List associated with immune checkpoint modulators (ICMs), drawn from the larger set of symptoms. Existing FACIT items were mapped to the symptom list, and new items were written as needed to create the item library. The full item library of irAEs is comprised of 239 items, covering 142 unique symptoms across 75 inflammatory reactions/immune conditions. A subset of 66 items comprises a Primary Symptom List considered most common/relevant to ICM treatment. This includes gastrointestinal, skin, pulmonary, neurologic, musculoskeletal, and multiple miscellaneous and constitutional symptoms. The FACIT Immunotherapy Item Library is a compilation of 239 self-report items that capture the wide range of AEs experienced by people receiving immune treatments. A subset of 66 items comprises a Primary Symptom List meant for ICM therapy. Use of items selected from this library is encouraged in clinical research and clinical practice evaluation.

Déclaration de conflit d'intérêts

Conflicts of interest Heather S.L. Jim is a consultant for RedHill BioPharma Ltd and Janssen Scientific Affairs; Aaron R. Hansen is a consultant for Merck (compensated) and GSK (compensated), and has received grant/research support from (Clinical Trials for institution) from Genentech/Roche, Merck, GSK, Bristol-Myers Squibb, Novartis, Boston Biomedical, Boehringer-Ingelheim, AstraZeneca, Medimmune, Janssen, Karyopharm, and Macrogenics; David Cella is the President and owner of FACIT.org; Kimberly A. Webster is an owner of FACIT.org; Clifton O. Bingham III is a consultant to Bristol Myers Squibb, Regeneron/Sanofi, and Genentech/Roche, and has received grant support from Bristol Myers Squibb; Adam P. Dicker is an advisor for Roche, EMD Serono, Celldex, Janssen, Cybrexa, Self Care Catalysts, Oncohost, ThirdBridge, and Noxopharm (compensated), and to Google LaunchPad Accelerator, Dreamit Ventures, and Evolution Road (uncompensated). He has also provided expert testimony for Intellectual property (Wilson Soncini); Josephine Feliciano is a consultant to Astra Zeneca, Genentech, Eli Lilly, Pfizer, and Merck. Sheetal Kircher, Monica Janda, Laurie E. Steffen McLouth, N. Lynn Henry, Mary O’Connor and Kari Ala-leppilampi declare no relevant interests, financial or otherwise.